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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.7. Encorafenib

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of encorafenib, a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Encorafenib is a highly selective ATP-competitive small-molecule RAF kinase inhibitor acting on the RAS/RAF/MEK/ERK pathway in tumour cells expressing BRAF V600 mutations, including melanoma cell lines.

Encorafenib is indicated for use in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma, with BRAF V600 mutation.

Scheduling status

Encorafenib is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard that was in effect at the time the decision was made (Poisons Standard October 2017 (SUSMP No. 18)).

International regulations

Encorafenib is unclassified in New Zealand, Canada and the United States of America.

Delegate’s consideration

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

The delegate considered the following in regards to this application for scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2015) scheduling factors;
  • The TGA designation evaluation report; and
  • The new drug application.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate’s final decision

The delegate has made a final decision to amend the Poisons Standard to include encorafenib in Schedule 4, with an implementation date of 1 February 2018.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 – New Entry

ENCORAFENIB.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989are: (a) the risks and benefits of the use of a substance; and (c) the toxicity of a substance.

The delegate decided that the reasons for the final decision comprise the following:

  • Encorafenib is an NCE with no marketing experience in Australia.
  • Outside of the proposed usage, toxicity may result in a negative risk-benefit balance.

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